Trial Outcomes & Findings for B-cell Immunity to Influenza (SLVP017) - Years 2 (2010) & 3 (2011) (NCT NCT03020498)
NCT ID: NCT03020498
Last Updated: 2018-06-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
91 participants
Primary outcome timeframe
Day 0 to 28
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
Group A: 8-17 yo Identical Twins
Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray
|
Group B: 8-30 yo Non-twin
Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray
|
Group C: 70-100 yo Non-twin
Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
41
|
36
|
|
Overall Study
COMPLETED
|
14
|
38
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
B-cell Immunity to Influenza (SLVP017) - Years 2 (2010) & 3 (2011)
Baseline characteristics by cohort
| Measure |
Group A: 8-17 yo Identical Twins
n=14 Participants
Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray
|
Group B: 8-30 yo Non-twin
n=41 Participants
Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray
|
Group C: 70-100 yo Non-twin
n=36 Participants
Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.84 years
STANDARD_DEVIATION 3.53 • n=5 Participants
|
21.82 years
STANDARD_DEVIATION 5.32 • n=7 Participants
|
77.00 years
STANDARD_DEVIATION 5.313 • n=5 Participants
|
42.27 years
STANDARD_DEVIATION 28.86 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
41 participants
n=7 Participants
|
36 participants
n=5 Participants
|
91 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 28Outcome measures
| Measure |
Group A: 8-17 yo Identical Twins
n=14 Participants
Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray
|
Group B: 8-30 yo Non-twin
n=41 Participants
Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray
|
Group C: 70-100 yo Non-twin
n=36 Participants
Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
|
|---|---|---|---|
|
Number of Participants Who Received Influenza Vaccine
|
14 Participants
|
38 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Day 0 to 28 post-immunizationOutcome measures
| Measure |
Group A: 8-17 yo Identical Twins
n=14 Participants
Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray
|
Group B: 8-30 yo Non-twin
n=38 Participants
Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray
|
Group C: 70-100 yo Non-twin
n=36 Participants
Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
|
|---|---|---|---|
|
Number of Participants With Related Adverse Events
|
1 Participants
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 to 28Outcome measures
Outcome data not reported
Adverse Events
Group A: 8-17 yo Identical Twins
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group B: 8-30 yo Non-twin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group C: 70-100 yo Non-twin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A: 8-17 yo Identical Twins
n=14 participants at risk
Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray
|
Group B: 8-30 yo Non-twin
n=38 participants at risk
Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray
|
Group C: 70-100 yo Non-twin
n=36 participants at risk
Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection
|
|---|---|---|---|
|
Nervous system disorders
Light headedness
|
0.00%
0/14 • Day 0 to Day 28 of study participation
Clinical Assessment performed at each visit
|
2.6%
1/38 • Number of events 1 • Day 0 to Day 28 of study participation
Clinical Assessment performed at each visit
|
2.8%
1/36 • Number of events 1 • Day 0 to Day 28 of study participation
Clinical Assessment performed at each visit
|
|
Nervous system disorders
Syncope
|
7.1%
1/14 • Number of events 1 • Day 0 to Day 28 of study participation
Clinical Assessment performed at each visit
|
0.00%
0/38 • Day 0 to Day 28 of study participation
Clinical Assessment performed at each visit
|
0.00%
0/36 • Day 0 to Day 28 of study participation
Clinical Assessment performed at each visit
|
Additional Information
Dr. Cornelia Dekker
Stanford University School of Medicine, Dept. of Pediatrics
Phone: 650-724-4437
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place